The prevalence and burden of overactive bladder (OAB) in the population is remarkable. An estimated 20 million adult women in the United States have symptoms of OAB. Despite the negative impact on their health-related quality of life, many do not seek treatment. Antimuscarinic agents for OAB have long been available only with a prescription. However, the Food and Drug Administration approved an over-the-counter (OTC) oxybutynin transdermal patch for use in women in 2013, and the product recently came to market. The availability of an OTC antimuscarinic medication for OAB introduces the opportunity for females to self-treat the condition. Prior to the prescription-to-OTC switch, the efficacy and safety data for the prescription product were evaluated. Consumer research studies guided the development of the drug label.
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